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FDA 510(k) Application Details - K032967
Device Classification Name
Tonometer, Manual
More FDA Info for this Device
510(K) Number
K032967
Device Name
Tonometer, Manual
Applicant
SMT SWISS MICROTECHNOLOGY AG
13 RED FOX LANE
LITTLETON, CO 80127 US
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Contact
Kevin Walls
Other 510(k) Applications for this Contact
Regulation Number
886.1930
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Classification Product Code
HKY
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More FDA Info for this Product Code
Date Received
09/23/2003
Decision Date
11/14/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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